Arterial Closure in Transfemoral PCI May Offer Clinical Benefit, but Cost-Effectiveness Unclear

(UPDATED) Interventional cardiologists who perform transfemoral PCI vary substantially in whether they choose to use arterial closure devices (ACDs) instead of manual compression, according to a registry study. But the devices—although associated with a small but significant benefit with regard to vascular access site complications—might not be cost-effective, given the infrequency of these events in the first place.

Previous randomized studies appraising the efficacy of ACDs in clinical practice have generally been underpowered and outdated, and the biggest meta-analysis—published more than a decade ago in 2004—hinted at an increased risk of complications with their use. Nonetheless, operators have developed personal preferences for when to use them and in which patients.

Drawing on the NCDR CathPCI registry, lead author Neil Wimmer, MD (Christiana Care Health System, Newark, DE), and colleagues evaluated more than two million PCIs performed at 1,470 US sites between 2009 and 2013. More than one million ACDs were used, with PAD patients and those with severe symptoms of heart failure less likely to receive them.

Use of ACDs “did not seem to be related to measured patient or physician factors,” write the authors. If anything, they say, “these findings highlight the lack of strong evidence supporting the use of such devices, creating the preconditions for unexplained variation in care.”

Overall, 1.5% of patients experienced some type of vascular complication. Through a unique “instrumental variable approach” designed to balance out potential confounding associated with the wide physician practice variation, Wimmer and colleagues estimated a 0.36% absolute risk reduction in these complications (95% CI 0.31-0.42%; P < 0.001) with a number needed to treat of 250.

Looking at non-access site bleeding, which should not be affected by ACD use, there was only a 0.04% absolute difference in risk between those who received the devices and those who had manual compression (95% CI 0.01-0.07%; P = 0.007). This suggests “acceptable control of confounding in the comparison,” the author write.

Use of ACDs also was associated with a 0.73% risk reduction in major bleeding (95% CI 0.64-0.82%) and a 0.12 day reduction in hospital length of stay (95% CI 0.10-0.13 days), but they did not have any impact on in-hospital mortality.

Cost-Benefit Analysis Warranted

“Although our findings suggest that ACDs are associated with some clinical benefit, we conclude that that benefit is relatively small in terms of preventing complications,” Wimmer et al note.

Perhaps a larger benefit of ACDs, however, is the convenience associated with the devices, “in that they reduce the time patients need to lie in bed and don’t require a person to hold pressure on a groin, which can be uncomfortable,” senior author Robert Yeh, MD (Beth Israel Deaconess Medical Center, Boston, MA), told TCTMD in an email. “But as we have moved more and more toward radial access for routine PCI, it has become less of an issue.”

Per use, ACDs do not cost all that much money, the authors write, but with such low rates of vascular and bleeding complications today, “even interventions that are highly efficacious would still have a relatively large cost per complication prevented.” Because of this, Wimmer and colleagues suggest future research include a “detailed cost-benefit analysis.”

To better avoid complications altogether, the authors advise using radial access for more patients—a strategy that has been associated with better patient outcomes. Additionally, better decisions in antithrombotic and antiplatelet therapy could also “have a much larger effect in preventing bleeding or access-site complications overall,” they write.

The unique design of the study made it unable to test differences in outcomes between different ACDs, but the authors acknowledge that “the effectiveness of some ACDs may be different from others.” They also were not able to account for the effects of the learning curve for operators using these devices. And since events were not adjudicated, there is the potential for over- or underreporting.

Overall, Yeh said the findings have increased his confidence in the ability for ACDs to lower patients’ bleeding risk, especially in cases involving larger diameter sheaths. “I don’t use [ACDs] routinely, however, as we have moved to radial access in most cases, and they are probably not particularly cost-effective,” he said.

• Wimmer NJ, Secemsky EA, Mauri L, et al. Effectiveness of arterial closure devices for preventing complications with percutaneous coronary intervention: an instrumental variable analysis. Circ Cardiovasc Interv. 2016;Epub ahead of print.

Related Stories:

• AHA Statement Offers Guidance on Arterial Closure Device Use
• ISAR-CLOSURE: Vascular Closure Devices Noninferior to Manual Compression in Transfemoral Angiography
• Registry: Closure Devices Reduce Vascular Complications After Transfemoral PCI